Important Safety Information Regarding the Use of Sleep Aid Drugs and the Risk of Complex Sleep-Related Behaviours

Important Safety Information Regarding the Use of Sleep Aid Drugs and the Risk of Complex Sleep-Related Behaviours

2009-161

OTTAWA – Health Canada is informing consumers and health professionals of recent changes to the labelling information of prescription sleep aid medications used in the short-term treatment of insomnia.

Sleep aid drugs are used for short-term treatment of insomnia characterized by difficulty in falling asleep, or waking up often during the night or in the early morning hours. The new labelling describes reports of complex sleep-related behaviours that have occurred while patients using these drugs were not fully awake, such as talking, walking, cooking, eating, and driving. Patients typically did not remember these events afterwards.

The new labelling also emphasizes the proper use of these medications. In particular, sleep aid medications (also called sedative-hypnotic medications) should not be taken with alcohol, and patients should not take more than the prescribed dose. Caution should be used when taking sleep aid medications at the same time as other drugs that can cause drowsiness, such as other tranquilizers or sleeping pills, antihistamines that cause drowsiness, anticonvulsants, painkillers that contain narcotics, and medicines used to treat depression or anxiety.

Patients and people close to them are encouraged to be aware of these types of sleep-related behaviours. Patients should report any suspected events to their health care professional. Discontinuing sleep aid medication should be considered for patients who report complex sleep-related behaviours, due to the risk of harm to the patient and to others. These medications should only be discontinued by an individual after consulting with their health care professional, as abrupt discontinuation may cause symptoms of withdrawal.

The sleep-aid medications with potential risk of complex sleep-related behaviours include flurazepam, nitrazepam, temazepam, triazolam, zopiclone, zolpidem, and zaleplon. While authorized by Health Canada, zolpidem and zaleplon are not currently sold in Canada but may become available in the future.

Health Canada has worked with manufacturers to update the labelling of the following brand-name sleep aid drugs:

•Dalmane, Som Pam (flurazepam)
•Mogadon, Nitrazadon (nitrazepam)
•Restoril (temazepam)
•Apo-Triazo (triazolam)
•Imovane, Rhovane (zopiclone)

The updated Canadian product monographs for these drugs can be found by search of the Drug Product Database on the Health Canada website. The product monographs for the generic formulations (see the following list of Authorized sleep-aid medications in Canada for a list of generic sleep-aid drugs) will be updated in the future; patients taking generic sleep-aid drugs may at this time consult the Product Monographs of the brand-name products for the updated information.

Patients should typically not take sleep aid drugs for more than 7 to 10 days in a row. The drugs affected by this labelling change are all available by prescription only in Canada.

Any patient who has concerns or questions about the use of sleep-aid drugs should talk to their health care professional.

Consumers requiring more information about this Information Update can contact Health Canada's public enquiries line at (613) 957-2991, or toll free at 1-866-225-0709.

You can report any adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following three ways:

•Report online at the MedEffect™ Canada section of the Health Canada website
•Call toll-free at 1-866-234-2345
•Complete a Canada Vigilance Reporting Form and either: Fax toll-free to 1-866-678-6789 Mail to: Canada Vigilance ProgramHealth CanadaAL 0701C Ottawa, ON K1A 0K9

Media Enquiries:Health Canada(613) 957-2983

Public Enquiries:(613) 957-29911-866 225-0709